The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove - Aqua Blue (ablu) / Violet Blue (vblu) / Dark Blue (dkbu).
| Device ID | K140610 |
| 510k Number | K140610 |
| Device Name: | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA NGC SDN. BHD. C-G-9, JALAN DATARAN SD1 Bandar Sri Damansara, MY 52200 |
| Contact | Nurul Aisyah Kong |
| Correspondent | Nurul Aisyah Kong HARTALEGA NGC SDN. BHD. C-G-9, JALAN DATARAN SD1 Bandar Sri Damansara, MY 52200 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-10 |
| Decision Date | 2014-06-20 |
| Summary: | summary |